US pharma major Eli Lilly (NYSE: LLY) has announced positive results from the Phase III REGARD trial of ramucirumab (IMC-1121B) as a single agent in patients with advanced gastric cancer who have had disease progression after initial chemotherapy were published today in The Lancet.
REGARD is the first Phase III study with either a single-agent biologic or an anti-angiogenic therapy to show improved overall survival and progression-free survival in advanced gastric cancer patients.
REGARD is a global, randomized, double-blind Phase III study of ramucirumab and best supportive care compared to placebo and best supportive care as treatment in patients with advanced gastric cancer following progression after initial chemotherapy. Patients (n=355) were randomly assigned in a 2:1 ratio, to receive best supportive care plus either ramucirumab 8mg/kg or placebo, intravenously once every two weeks. Median duration of treatment was eight weeks in the ramucirumab group and six weeks in the placebo group.
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